Today, the Italian Medicines Agency (AIFA) welcomed a delegation from the Greek Ministry of Health, accompanied by representatives from the European Commission and WHO Europe, for a study day focused on Health Technology Assessment (HTA). The meeting concentrated on the strategies adopted by AIFA to ensure access to innovative, increasingly targeted, and high-cost medicines, while safeguarding the sustainability of the healthcare system. This model is being considered for adaptation and implementation in Greece, where the Ministry of Health is pursuing a series of reforms to modernise pharmaceutical care and improve access to innovation.

The visit forms part of activities under the Technical Support Instrument (TSI), a programme funded and managed by the European Commission’s Reform and Investment Working Group (SG REFORM). Its aim is to promote the exchange of technical expertise and best practices for developing new HTA processes and guidelines aligned with the new EU HTA regulation.

AIFA experts presented the agency’s processes for price negotiation and reimbursement, the innovativeness assessment framework, and tools for managing pharmaceutical expenditure. The visit was organised in collaboration with AGENAS, where the delegation will continue their study programme tomorrow.

“I am pleased to welcome the Greek delegation to AIFA and to share the significant work we’ve done to make innovative medicines more accessible to patients,” said AIFA’s President Robert Nisticò. “In 2024, the EMA authorised 114 new medicines, 112 of which were reviewed this year. We have surpassed pre-pandemic levels, facing a wave of new, high-cost medicines. It is crucial to assess the added therapeutic value of these treatments using new tools and to reward true innovation by implementing shared strategies to harmonise access to therapies across Europe. This is a challenge not only for Italy but for all countries.”

“Today’s visit marks a significant step in strengthening HTA in Greece, as part of the ongoing TSI project at our Ministry of Health. It also presents an opportunity to deepen cooperation between our two countries,” said Aris Angelis, Secretary General for Strategic Planning at the Greek Ministry of Health. “AIFA’s experience in HTA, including national registries and Managed Entry Agreements for new products, offers valuable insights that can support our efforts. The discussions on pricing, reimbursement, innovativeness assessment, and pharmaceutical spending management align closely with our national priorities.

“I would like to thank the Secretary General for Strategic Planning of the Greek Ministry of Health for his interest in AIFA’s tools aimed at improving patient access to innovative and high-cost medicines—particularly our national monitoring register platform,” said Pierluigi Russo, AIFA’s Technical-Scientific Director. “This platform is a European benchmark, especially in healthcare systems with a strong universalist approach. We are pleased to support the Greek Ministry of Health, even beyond the TAIEX programme, in developing a national system to monitor priority medicines and enable access mechanisms based on economic agreements.”